PMID- 35212487
OWN - NLM
STAT- MEDLINE
DCOM- 20220421
LR  - 20220716
IS  - 2523-3548 (Electronic)
IS  - 2523-3548 (Linking)
VI  - 42
IP  - 4
DP  - 2022 Apr
TI  - XELOX doublet regimen versus EOX triplet regimen as first-line treatment for 
      advanced gastric cancer: An open-labeled, multicenter, randomized, prospective 
      phase III trial (EXELOX).
PG  - 314-326
LID - 10.1002/cac2.12278 [doi]
AB  - BACKGROUND: There is no consensus on whether triplet regimen is better than 
      doublet regimen in the first-line treatment of advanced gastric cancer (AGC). We 
      aimed to compare the efficacy and safety of oxaliplatin plus capecitabine (XELOX) 
      and epirubicin, oxaliplatin, plus capecitabine (EOX) regimens in treating AGC. 
      METHODS: This phase III trial enrolled previously untreated patients with AGC who 
      were randomly assigned to receive the XELOX or EOX regimen. The primary endpoint 
      was non-inferiority in progression-free survival (PFS) for XELOX as compared with 
      EOX on an intention-to-treat basis. RESULTS: Between April 10, 2015 and August 
      20, 2020, 448 AGC patients were randomized to receive XELOX (n = 222) or EOX (n = 
      226). The median PFS (mPFS) was 5.0 months (95% confidence interval [CI] = 
      4.5-6.0 months) in the XELOX arm and 5.5 months (95% CI = 5.0-6.0 months) in the 
      EOX arm (hazard ratio [HR] = 0.989, 95% CI = 0.812-1.203; P(non-inferiority) = 
      0.003). There was no significant difference in median overall survival (mOS) 
      (12.0 vs. 12.0 months, P = 0.384) or objective response rate (37.4% vs. 45.1%, P 
      = 0.291) between the two groups. In patients with poorly differentiated 
      adenocarcinoma and liver metastasis, the EOX arm had a significantly longer mOS 
      (P = 0.021) and a trend of longer mPFS (P = 0.073) than the XELOX arm. The rate 
      of grade 3/4 adverse events (AEs) was 42.2% (90/213) in the XELOX arm and 72.5% 
      (156/215) in the EOX arm (P = 0.001). The global health-related quality of life 
      (QoL) score was significantly higher in the XELOX arm than in the EOX arm during 
      chemotherapy. CONCLUSIONS: This non-inferiority trial demonstrated that the 
      doublet regimen was as effective as the triplet regimen and had a better safety 
      profile and QoL as a first-line treatment for AGC patients. However, the triplet 
      regimen might have a survival advantage in patients with poorly differentiated 
      adenocarcinoma and liver metastasis.
CI  - (c) 2022 The Authors. Cancer Communications published by John Wiley & Sons 
      Australia, Ltd. on behalf of Sun Yat-sen University Cancer Center.
FAU - Zhu, Xiao-Dong
AU  - Zhu XD
AD  - Department of Gastrointestinal Medical Oncology, Fudan University Shanghai Cancer 
      Center, Shanghai, 200032, P. R. China.
AD  - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, 
      200032, P. R. China.
FAU - Huang, Ming-Zhu
AU  - Huang MZ
AD  - Department of Gastrointestinal Medical Oncology, Fudan University Shanghai Cancer 
      Center, Shanghai, 200032, P. R. China.
AD  - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, 
      200032, P. R. China.
FAU - Wang, Yu-Sheng
AU  - Wang YS
AD  - Department of Gastroenterology, Shanxi Cancer Hospital, Taiyuan, Shanxi, 030013, 
      P. R. China.
FAU - Feng, Wan-Jing
AU  - Feng WJ
AD  - Department of Gastrointestinal Medical Oncology, Fudan University Shanghai Cancer 
      Center, Shanghai, 200032, P. R. China.
AD  - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, 
      200032, P. R. China.
FAU - Chen, Zhi-Yu
AU  - Chen ZY
AD  - Department of Gastrointestinal Medical Oncology, Fudan University Shanghai Cancer 
      Center, Shanghai, 200032, P. R. China.
AD  - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, 
      200032, P. R. China.
FAU - He, Yi-Fu
AU  - He YF
AD  - Department of Medical Oncology, The First Affiliated Hospital, Division of Life 
      Science and Medicine, University of Science and Technology of China, Hefei, 
      Anhui, 230031, P. R. China.
FAU - Zhang, Xiao-Wei
AU  - Zhang XW
AD  - Department of Gastrointestinal Medical Oncology, Fudan University Shanghai Cancer 
      Center, Shanghai, 200032, P. R. China.
AD  - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, 
      200032, P. R. China.
FAU - Liu, Xin
AU  - Liu X
AD  - Department of Gastrointestinal Medical Oncology, Fudan University Shanghai Cancer 
      Center, Shanghai, 200032, P. R. China.
AD  - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, 
      200032, P. R. China.
FAU - Wang, Chen-Chen
AU  - Wang CC
AD  - Department of Gastrointestinal Medical Oncology, Fudan University Shanghai Cancer 
      Center, Shanghai, 200032, P. R. China.
AD  - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, 
      200032, P. R. China.
FAU - Zhang, Wen
AU  - Zhang W
AD  - Department of Gastrointestinal Medical Oncology, Fudan University Shanghai Cancer 
      Center, Shanghai, 200032, P. R. China.
AD  - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, 
      200032, P. R. China.
FAU - Ying, Jie-Er
AU  - Ying JE
AD  - Department of Abdominal Medical Oncology, Cancer Hospital of the University of 
      Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Cancer and 
      Basic Medicine (IBMC) Chinese Academy of Sciences, Hangzhou, Zhejiang, 310005, P. 
      R. China.
FAU - Wu, Jun
AU  - Wu J
AD  - Department of Medical Oncology, The First People's Hospital of Changzhou, 
      Changzhou, Jiangsu, 213004, P. R. China.
FAU - Yang, Lei
AU  - Yang L
AD  - Department of Gastroenterology, Nantong Tumor Hospital, Nantong, Jiangsu, 226006, 
      P. R. China.
FAU - Qin, Yan-Ru
AU  - Qin YR
AD  - Department of Oncology, Zhengzhou University First Affiliated Hospital, 
      Zhengzhou, Henan, 450052, P. R. China.
FAU - Luo, Jian-Feng
AU  - Luo JF
AD  - Department of Biostatistics, School of Public Health, Fudan University, Shanghai, 
      200032, P. R. China.
FAU - Zhao, Xiao-Ying
AU  - Zhao XY
AD  - Department of Gastrointestinal Medical Oncology, Fudan University Shanghai Cancer 
      Center, Shanghai, 200032, P. R. China.
AD  - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, 
      200032, P. R. China.
FAU - Li, Wen-Hua
AU  - Li WH
AD  - Department of Gastrointestinal Medical Oncology, Fudan University Shanghai Cancer 
      Center, Shanghai, 200032, P. R. China.
AD  - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, 
      200032, P. R. China.
FAU - Zhang, Zhe
AU  - Zhang Z
AD  - Department of Gastrointestinal Medical Oncology, Fudan University Shanghai Cancer 
      Center, Shanghai, 200032, P. R. China.
AD  - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, 
      200032, P. R. China.
FAU - Qiu, Li-Xin
AU  - Qiu LX
AD  - Department of Gastrointestinal Medical Oncology, Fudan University Shanghai Cancer 
      Center, Shanghai, 200032, P. R. China.
AD  - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, 
      200032, P. R. China.
FAU - Geng, Qi-Rong
AU  - Geng QR
AD  - Department of Gastrointestinal Medical Oncology, Fudan University Shanghai Cancer 
      Center, Shanghai, 200032, P. R. China.
AD  - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, 
      200032, P. R. China.
FAU - Zou, Jian-Ling
AU  - Zou JL
AD  - Department of Gastrointestinal Medical Oncology, Fudan University Shanghai Cancer 
      Center, Shanghai, 200032, P. R. China.
AD  - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, 
      200032, P. R. China.
FAU - Zhang, Jie-Yun
AU  - Zhang JY
AD  - Department of Gastrointestinal Medical Oncology, Fudan University Shanghai Cancer 
      Center, Shanghai, 200032, P. R. China.
AD  - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, 
      200032, P. R. China.
FAU - Zheng, Hong
AU  - Zheng H
AD  - Department of medical oncology, Cancer Hospital of Fudan University, Minhang 
      Branch, Shanghai, 200032, P. R. China.
FAU - Song, Xue-Feng
AU  - Song XF
AD  - Department of Gastroenterology, Shanxi Cancer Hospital, Taiyuan, Shanxi, 030013, 
      P. R. China.
FAU - Wu, Shu-Sheng
AU  - Wu SS
AD  - Department of Medical Oncology, The First Affiliated Hospital, Division of Life 
      Science and Medicine, University of Science and Technology of China, Hefei, 
      Anhui, 230031, P. R. China.
FAU - Zhang, Cheng-Yan
AU  - Zhang CY
AD  - Department of Gastroenterology, Shanxi Cancer Hospital, Taiyuan, Shanxi, 030013, 
      P. R. China.
FAU - Gong, Zhe
AU  - Gong Z
AD  - Department of Gastrointestinal Medical Oncology, Fudan University Shanghai Cancer 
      Center, Shanghai, 200032, P. R. China.
AD  - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, 
      200032, P. R. China.
FAU - Liu, Qin-Qin
AU  - Liu QQ
AD  - Department of Gastrointestinal Medical Oncology, Fudan University Shanghai Cancer 
      Center, Shanghai, 200032, P. R. China.
AD  - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, 
      200032, P. R. China.
FAU - Wang, Xiao-Feng
AU  - Wang XF
AD  - Department of Oncology, Zhengzhou University First Affiliated Hospital, 
      Zhengzhou, Henan, 450052, P. R. China.
FAU - Xu, Qi
AU  - Xu Q
AD  - Department of Abdominal Medical Oncology, Cancer Hospital of the University of 
      Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Cancer and 
      Basic Medicine (IBMC) Chinese Academy of Sciences, Hangzhou, Zhejiang, 310005, P. 
      R. China.
FAU - Wang, Qi
AU  - Wang Q
AD  - Department of Medical Oncology, The First People's Hospital of Changzhou, 
      Changzhou, Jiangsu, 213004, P. R. China.
FAU - Ji, Jian-Mei
AU  - Ji JM
AD  - Department of Gastroenterology, Nantong Tumor Hospital, Nantong, Jiangsu, 226006, 
      P. R. China.
FAU - Zhao, Jian
AU  - Zhao J
AD  - Department of Gastroenterology, Shanxi Cancer Hospital, Taiyuan, Shanxi, 030013, 
      P. R. China.
FAU - Guo, Wei-Jian
AU  - Guo WJ
AD  - Department of Gastrointestinal Medical Oncology, Fudan University Shanghai Cancer 
      Center, Shanghai, 200032, P. R. China.
AD  - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, 
      200032, P. R. China.
LA  - eng
SI  - ClinicalTrials.gov/NCT02395640
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20220225
PL  - United States
TA  - Cancer Commun (Lond)
JT  - Cancer communications (London, England)
JID - 101723675
RN  - 0 (Oxaloacetates)
RN  - 04ZR38536J (Oxaliplatin)
RN  - 6804DJ8Z9U (Capecitabine)
RN  - XELOX
SB  - IM
MH  - *Adenocarcinoma/drug therapy
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects
MH  - Capecitabine
MH  - Humans
MH  - *Liver Neoplasms/drug therapy
MH  - Oxaliplatin
MH  - Oxaloacetates
MH  - Prospective Studies
MH  - Quality of Life
MH  - *Stomach Neoplasms/pathology
PMC - PMC9017757
OTO - NOTNLM
OT  - Advanced gastric cancer, chemotherapy, XELOX doublet regimen
OT  - EOX triplet regimen, non-inferiority, quality of life, phase III trial
COIS- The authors declare no potential conflicts of interest.
EDAT- 2022/02/26 06:00
MHDA- 2022/04/22 06:00
PMCR- 2022/02/25
CRDT- 2022/02/25 08:39
PHST- 2021/11/10 00:00 [revised]
PHST- 2021/08/30 00:00 [received]
PHST- 2022/02/15 00:00 [accepted]
PHST- 2022/02/26 06:00 [pubmed]
PHST- 2022/04/22 06:00 [medline]
PHST- 2022/02/25 08:39 [entrez]
PHST- 2022/02/25 00:00 [pmc-release]
AID - CAC212278 [pii]
AID - 10.1002/cac2.12278 [doi]
PST - ppublish
SO  - Cancer Commun (Lond). 2022 Apr;42(4):314-326. doi: 10.1002/cac2.12278. Epub 2022 
      Feb 25.